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1. Efficacy and tolerability of a 4-month ofloxacin-containing regimen compared to a 6-month regimen in the treatment of patients with superficial lymph node tuberculosis: a randomized trial

Author

Hissar, Syed, Velayutham, Banurekha, Tamizhselvan, Manoharan, Rathinam, Sridhar, Arunbabu, Chinnadurai, Vidhya, Jayanthi Bharathi, Vargunapandian, Gurusamy, Sundararajaperumal, Anandakrishnan, Sivaramakrishnan, Gomathi Narayan, Chelvi, Silambu, Ramesh, Paranchi Murugesan, Arun, Damodharan, Reddy, Sirasanambati Devarajulu, Kumaran, Paramasivam Paul, Kumar, Marimuthu Makesh, Kalaiselvi, Dharuman, Hanna, Luke Elizabeth, Kumar, Hemanth, Gowrisankar, Alagarsamy, Rajavelu, Ramasamy, Jayabal, Lavanya, Ponnuraja, Chinnayan, and Baskaran, Dhanaraj

Published
2024
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2. Sex-specific differences in systemic immune responses in MIS-C children

Author

Rajamanickam, Anuradha, Kumar, Nathella Pavan, Venkataraman, Aishwarya, Varadarjan, Poovazhagi, Selladurai, Elilarasi, Sankaralingam, Thangavelu, Thiruvengadam, Kannan, Selvam, Ramya, Thimmaiah, Akshith, Natarajan, Suresh, Ramaswamy, Ganesh, Putlibai, Sulochana, Sadasivam, Kalaimaran, Sundaram, Balasubramanian, Hissar, Syed, Ranganathan, Uma Devi, and Babu, Subash

Published
2024
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3. Randomized Clinical Trial of High-Dose Rifampicin With or Without Levofloxacin Versus Standard of Care for Pediatric Tuberculous Meningitis: The TBM-KIDS Trial

Author

Paradkar, Mandar S, D, Bella Devaleenal, Mvalo, Tisungane, Arenivas, Ana, Thakur, Kiran T, Wolf, Lisa, Nimkar, Smita, Inamdar, Sadaf, Giridharan, Prathiksha, Selladurai, Elilarasi, Kinikar, Aarti, Valvi, Chhaya, Khwaja, Saltanat, Gadama, Daphne, Balaji, Sarath, Kattagoni, Krishna Yadav, Venkatesan, Mythily, Savic, Radojka, Swaminathan, Soumya, Gupta, Amita, Gupte, Nikhil, Mave, Vidya, Dooley, Kelly E, Agiwal, Shivali, Ahire, Rupali, Balasubramanian, Usha, Bendre, Manjushree, Chandane, Jyoti, Chopade, Kavita, Dalimbkar, Shamala, Deshpande, Prasad, Dhage, Rajendra, Ithape, Mahesh, Jadhav, Varsha, Kante, Sonali, Kapre, Pallavi, Khan, Nawshaba, Kulkarni, Vandana, Madewar, Renu, Meshram, Shashibhushan, Muttha, Kunal, Nadgeri, Vaishali, Nagargoje, Arti, Nagraj, Amita, Nijampurkar, Aparna, Onawale, Prerana, Pawar, Namrata, Pawar, Prashant, Pradhan, Neeta, Shaikh, Varsha, Shaikh, Zaheda, Shere, Dhananjay, Wani, Gouri, Kulkarni, Rajesh, Rajput, Uday, Ganesan, Mangalambal, Arasan, Gunasundari, Shankar, Shakila, Mary, S Stella, Karuppaiah, Sureshwari, Pauline, Leema, Pramila, Snegha Karunakaran, Arul, Priyadharshini, Ganesh, Sankar, Hanna, Luke Elizabeth, Ramesh, K, Kannan, M, Vijayakumar, Ruthra, Sivakumar, Surekha S, Devika, K, Radhakrishnan, A, Preethi, AR, Rajkumar, S, Saravanan, N, Ramachandran, Geetha, Kumar, AK Hemanth, Dharman, M, Sudha, V, Hissar, Syed, Nagarajan, Valarmathi, Jennifer, Linda, Supriya, R, Manimegalai, R, Kandan, Santhanam, Maniselvi, Archana, Puspha, Oli, Vaishnavi, S, Selvi, R, Neelakandan, Logeswari, Chiunda, Mary, Chunga, Moreen, Kamanga, Madalo, Kamthunzi, Portia, Kanthiti, Elizabeth, Mbewe, Abineli, Msiska, Emmie, Mumba, Noel, Phiri, Ian Zifa, Palichina, Victor, and Sichali, Dorothy

Subjects
Pediatric, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Child, Humans, Rifampin, Tuberculosis, Meningeal, Levofloxacin, Ethambutol, Antitubercular Agents, Standard of Care, pediatric tuberculous meningitis, neuropsychological, clinical trial, levofloxacin, high-dose rifampicin, TuBerculous Meningitis in Kids (TBM-KIDS) Study Team, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundPediatric tuberculous meningitis (TBM) commonly causes death or disability. In adults, high-dose rifampicin may reduce mortality. The role of fluoroquinolones remains unclear. There have been no antimicrobial treatment trials for pediatric TBM.MethodsTBM-KIDS was a phase 2 open-label randomized trial among children with TBM in India and Malawi. Participants received isoniazid and pyrazinamide plus: (i) high-dose rifampicin (30 mg/kg) and ethambutol (R30HZE, arm 1); (ii) high-dose rifampicin and levofloxacin (R30HZL, arm 2); or (iii) standard-dose rifampicin and ethambutol (R15HZE, arm 3) for 8 weeks, followed by 10 months of standard treatment. Functional and neurocognitive outcomes were measured longitudinally using Modified Rankin Scale (MRS) and Mullen Scales of Early Learning (MSEL).ResultsOf 2487 children prescreened, 79 were screened and 37 enrolled. Median age was 72 months; 49%, 43%, and 8% had stage I, II, and III disease, respectively. Grade 3 or higher adverse events occurred in 58%, 55%, and 36% of children in arms 1, 2, and 3, with 1 death (arm 1) and 6 early treatment discontinuations (4 in arm 1, 1 each in arms 2 and 3). By week 8, all children recovered to MRS score of 0 or 1. Average MSEL scores were significantly better in arm 1 than arm 3 in fine motor, receptive language, and expressive language domains (P

Published
2022

6. Inadequate Lopinavir Concentrations With Modified 8-Hourly Lopinavir/Ritonavir 4: 1 Dosing During Rifampicin-based Tuberculosis Treatment in Children Living With HIV

Author

Chabala, Chishala, Turkova, Anna, Kapasa, Monica, LeBeau, Kristen, Tembo, Chimuka H., Zimba, Kevin, Weisner, Lubbe, Zyambo, Khozya, Choo, Louise, Chungu, Chalilwe, Lungu, Joyce, Mulenga, Veronica, Crook, Angela, Gibb, Diana, McIlleron, Helen, Gibb, Diana M., Turkova, Anna, Crook, Angela M., Choo, Louise, Wills, Genevieve, Thomason, Margaret J., Teera, Jaqueline, Owen- Powell, Ellen, LeBeau, Kristen, Baptiste, David, McGowan, Charlotte, Spyer, Moira, Chabala, Chishala, Mulenga, Veronica, Lungu, Joyce, Kapasa, Monica, Zimba, Kevin, Zyambo, Khozya, Chungu, Chalilwe, Tembo, Chimuka, Kunda, Sharon, Shingalili, Ellen, Zulu, Semy, Chipoya, Terence, Mwanakalanga, Habulembe, Chambela, Elias, Hankombo, Jessy M., Kalumbi, Mox Malama, Chola, Daniel, Malama, Stephen, Wobudeya, Eric, Musoke, Philippa, Baldwin, Mboizi Robert, Nansamba, Winnie, Ssenyonga, Mark, Ssengooba, Willy, Businge, Gerald, Hesseling, Anneke C., Palmer, Megan, van der Zalm, Marieke M., Workman, Jessica, Demers, Anne-Marie, Schaaf, Simon, Gie, Robert, Walters, Elisabetta, Zimri, Warren, Hoddinott, Graeme, Deventer, Anneen van, Goussard, Pierre, Morrison, Julie, Mave, Vidya, (PI), Kinikar, Aarti Avinash, Raichur, Priyanka, Nijampurkar, Aparna, Khan, Sameer, Hissar, Syed, Joseph, Bency, Bhavani, Perumal Kannabiran, Prathiksha, G, Baskaran, Dhanaraj, Gomathi, NS, Mythily, V, Kumar, Hemanth, Chelvi, Silambu, Sekar, L, Hanna, Luke, Ramesh, K, Latha, Hema, Bharathi, S, Banu, Parveen, Xavier, Dino, Kumar, Manjith, Guru, K, Kumar, Sasi, Kesavan, A, Gunasundari, A, Mangalambal, G, Nagarajan, Valarmathi, Shankar, Shakeela, Selvi, R, Vaishnavi, S, Yadav, Krishna, Supriya, R, Giranab, Hema, Seetha, A, Mary, Stella, Gopika, S, Rohini, S, Revathy, M, Balaji, Sarath, Elilarasi, S, Ganesh, J, Aravind, MA, Mulambo, Sylvia, Mwanyungwi, Hope, Tapse, Dharati, Sane, Manasi, Abdullah, Amina, Nakalanzi, Sarah, Williams, Cynthia Mukisa, McIlleron, Helen, Aarnoutse, Rob, Revill, Paul, Love-Koh, James, Walker, Simon, Mugyenyi, Peter, Darbyshire, Janet, Clayden, Polly, Donald, Peter, Singh, Varinder, Grzemska*, Malgosia, Swaminathan, Soumya, Verkuijl, *Replaced by Sabine, Peto, Tim, Mwinga, Alwyn, Fielding, Katherine, Graham, Stephen M., Welch, Steven B., Seddon, James A., Whittaker, Elizabeth, Anderson, Suzanne, and Grandjean, Louis

Published
2023
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7. Paediatric pulmonary disease—are we diagnosing it right?

Author

Rajendran, Priya, primary, Thomas, Silla Varghese, additional, Balaji, Sarath, additional, Selladurai, Elilarasi, additional, Jayachandran, Ganesh, additional, Malayappan, Aravind, additional, Bhaskar, Adhin, additional, Palanisamy, Sivaraman, additional, Ramamoorthy, Thirumalani, additional, Hasini, Sindhu, additional, and Hissar, Syed, additional

Published
2024
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8. Elucidating the Immune Response to SARS-CoV-2: Natural Infection versus Covaxin/Covishield Vaccination in a South Indian Population.

Author

Vanamudhu, Agalya, Devi Arumugam, Renuka, Nancy, Arul, Selvaraj, Nandhini, Moiden, Kadar, Hissar, Syed, Ranganathan, Uma Devi, Bethunaickan, Ramalingam, Babu, Subash, and Kumar, Nathella Pavan

Abstract

A natural infection or a vaccination can initially prime the immune system to form immunological memory. The immunity engendered by vaccination against COVID-19 versus natural infection with SARS-CoV-2 has not been well studied in the Indian population. In this study, we compared the immunity conferred by COVID-19 vaccines to naturally acquired immunity to SARS-CoV-2 in a South Indian population. We examined binding and neutralizing antibody (NAb) levels against the ancestral and variant lineages and assessed the ex vivo cellular parameters of memory T cells, memory B cells, and monocytes and finally measured the circulating cytokine response. COVID-19 vaccination stimulates heightened levels of IgG antibodies against the original strain of SARS-CoV-2, as well as increased binding to the spike protein and neutralizing antibody levels. This enhanced response extends to variant lineages such as B.1.617.2 (Delta, India), B.1.1.529 (Omicron, India), B.1.351 (Beta, South Africa), and B.1.1.7 (Alpha, UK). COVID-19 vaccination differs from SARS-CoV-2 infection by having increased frequencies of classical memory B cells, activated memory B and plasma cells, CD4/CD8 T cells of effector memory, effector cells, stem cell-like memory T cells, and classical and intermediate monocytes and diminished frequencies of CD4/CD8 T cells of central memory and non-classical monocytes in vaccinated individuals in comparison to those with natural infection. Thus, COVID-19 vaccination is characterized by enhanced humoral responses and robust activation of innate and memory T cell responses in comparison to natural infection in a South Indian population. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial.

Author

Chabala, Chishala, Wobudeya, Eric, Zalm, Marieke M van der, Kapasa, Monica, Raichur, Priyanka, Mboizi, Robert, Palmer, Megan, Kinikar, Aarti, Hissar, Syed, Mulenga, Veronica, Mave, Vidya, Musoke, Philippa, Hesseling, Anneke C, McIlleron, Helen, Gibb, Diana, Crook, Angela, Turkova, Anna, and Team, the SHINE Trial

Subjects
DRUG therapy for tuberculosis, TUBERCULOSIS mortality, HIV infection complications, ANEMIA, SECONDARY analysis, LEANNESS, RESEARCH funding, VIRAL load, MALNUTRITION, HIV-positive persons, HOSPITAL care, CD4 lymphocyte count, HEMOGLOBINS, HIV infections, TREATMENT effectiveness, DESCRIPTIVE statistics, ANTITUBERCULAR agents, ODDS ratio, ANTI-HIV agents, COMPARATIVE studies, DISEASE relapse, ADVERSE health care events, CONFIDENCE intervals, CHILDREN
Abstract

Background Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial. Methods SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH. Results Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P =.07) but more underweight (weight-for-age z score, −2.3; (3.3, −0.8 versus −1.0; −1.8, −0.2; P <.01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P <.01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241–1134), and CD4% was 16% (10–26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3–4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42). Conclusions We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration.  ISRCTN63579542. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Distinct TB-antigen stimulated cytokine profiles as predictive biomarkers for unfavorable treatment outcomes in pulmonary tuberculosis.

Author

Pandiarajan, Arul Nancy, Kumar, Nathella Pavan, Selvaraj, Nandhini, Ahamed, Shaik Fayaz, Viswanathan, Vijay, Thiruvengadam, Kannan, Hissar, Syed, Shanmugam, Sivakumar, Bethunaickan, Ramalingam, Nott, Sujatha, Kornfeld, Hardy, and Babu, Subash

Subjects
TUBERCULOSIS, TREATMENT effectiveness, CYTOKINES, BIOMARKERS, IMMUNE response
Abstract

Introduction: The assessment of tuberculosis (TB) treatment outcomes predominantly relies on sputum culture conversion status. To enhance treatment management, it is crucial to identify non-sputum-based biomarkers that can predict unfavorable outcomes. Cytokines are widely studied as diagnostic biomarkers for active TB. However, their potential as indicators for unfavorable treatment outcomes remains uncertain. Methodology: This study was conducted within a well-characterized cohort comprising newly diagnosed patients with drug-sensitive pulmonary TB, confirmed through sputum smear and culture positivity. Our objective was to elucidate the TB antigen-stimulated cytokine profile at pre-treatment and at 2 months into anti-TB treatment (ATT) in patients with unfavorable treatment outcomes (cases, n = 27) in comparison to recurrence-free, microbiologically cured controls (n = 31). Whole blood was stimulated with TB antigens using the QuantiFERON In-tube gold method, and plasma supernatants were subjected to a panel of 14 cytokine measurements. Results: In our study, pre-treatment analysis revealed that eight cytokines (IL-2, IFN-γ, TNF-α, IL-6, IL-10, IL-17A, IL-18, and GM-CSF) were significantly elevated at baseline in cases compared to cured controls, both in unstimulated conditions and following TB antigen (CFP10, ESAT6, and TB7.7) stimulation. A similar pattern was observed at the 2-month mark of ATT, with eight cytokines (IL-2, IL-10, IL-13, IFN-γ, IL-6, IL-12p70, IL-17A, and TNF-α) showing significant differences between the groups. Importantly, no variations were detected following mitogen stimulation, underscoring that these distinctive immune responses are primarily driven by TB-specific antigens. Conclusion: Our findings indicate that individuals with unfavorable TB treatment outcomes display a characteristic cytokine profile distinct from TB-cured patients, even before commencing ATT. Therefore, the levels of specific cytokine pre-treatment and at the 2-month point in the course of treatment may serve as predictive immune markers for identifying individuals at risk of unfavorable TB treatment outcomes, with these responses being predominantly influenced by TB-specific antigens. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Multisystem inflammatory syndrome in children characterized by enhanced antigen-specific T-cell expression of cytokines and its reversal following recovery

Author

Pavan Kumar, Nathella, primary, Abbas, Kadar M., additional, Renji, Rachel M., additional, Venkataraman, Aishwarya, additional, Nancy, Arul, additional, Varadarjan, Poovazhagi, additional, Selladurai, Elilarasi, additional, Sangaralingam, Thankgavelu, additional, Selvam, Ramya, additional, Thimmaiah, Akshith, additional, Natarajan, Suresh, additional, Ramasamy, Ganesh, additional, Hissar, Syed, additional, Ranganathan, Uma Devi, additional, Nutman, Thomas B., additional, and Babu, Subash, additional

Published
2023
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15. Downregulation of monocyte miRNAs: implications for immune dysfunction and disease severity in drug-resistant tuberculosis

Author

Sampath, Pavithra, primary, Moorthy, Manju, additional, Menon, Athul, additional, Madhav, Lekshmi, additional, Janaki, Aishwarya, additional, Dhanapal, Madhavan, additional, Natarajan, Alangudi Palaniappan, additional, Hissar, Syed, additional, Ranganathan, Uma Devi, additional, Ramaswamy, Gopalakrishna, additional, and Bethunaickan, Ramalingam, additional

Published
2023
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17. Multisystem inflammatory syndrome in children characterized by enhanced antigen-specific T-cell expression of cytokines and its reversal following recovery.

Author

Kumar, Nathella Pavan, Abbas, Kadar M., Renji, Rachel M., Venkataraman, Aishwarya, Nancy, Arul, Varadarjan, Poovazhagi, Selladurai, Elilarasi, Sangaralingam, Thankgavelu, Selvam, Ramya, Thimmaiah, Akshith, Natarajan, Suresh, Ramasamy, Ganesh, Hissar, Syed, Ranganathan, Uma Devi, Nutman, Thomas B., and Babu, Subash

Published
2023
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19. Role of matrix metalloproteinases in multi-system inflammatory syndrome and acute COVID-19 in children

Author

Pavan Kumar, Nathella, primary, Venkataraman, Aishwarya, additional, Varadarjan, Poovazhagi, additional, Nancy, Arul, additional, Rajamanickam, Anuradha, additional, Selladurai, Elilarasi, additional, Sankaralingam, Thangavelu, additional, Thiruvengadam, Kannan, additional, Selvam, Ramya, additional, Thimmaiah, Akshith, additional, Natarajan, Suresh, additional, Ramaswamy, Ganesh, additional, Putlibai, Sulochana, additional, Sadasivam, Kalaimaran, additional, Sundaram, Balasubramanian, additional, Hissar, Syed, additional, Ranganathan, Uma Devi, additional, Nutman, Thomas B., additional, and Babu, Subash, additional

Published
2022
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20. Comparison of two mycobacterial strains in performance of the whole blood mycobacterial growth inhibition assay in Indian children

Author

Venkataraman, Aishwarya, primary, Shanmugam, Sivakumar, additional, Balaji, Sarath, additional, Mani, Karthick, additional, Shanmugavel, Ashok Kumar, additional, Muthuramalingam, Kannan, additional, Hissar, Syed, additional, Thiruvengadam, Kannan, additional, Selladurai, Elilarasi, additional, Smuk, Melanie, additional, Hanna, Luke Elizabeth, additional, and Prendergast, Andrew J., additional

Published
2022
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21. Unique cellular immune signatures of multisystem inflammatory syndrome in children

Author

Rajamanickam, Anuradha, primary, Nathella, Pavan Kumar, additional, Venkataraman, Aishwarya, additional, Varadarjan, Poovazhagi, additional, Kannan, Srinithi, additional, Pandiarajan, Arul Nancy, additional, Renji, Rachel Mariam, additional, Elavarasan, Elayarani, additional, Thimmaiah, Akshith, additional, Sasidaran, Kandasamy, additional, Krishnamoorthy, Nedunchelian, additional, Natarajan, Suresh, additional, Ramaswamy, Ganesh, additional, Sundaram, Balasubramanian, additional, Putlibai, Sulochana, additional, Hissar, Syed, additional, Selladurai, Elilarasi, additional, Uma Devi, K. Ranganathan, additional, Nutman, Thomas B., additional, and Babu, Subash, additional

Published
2022
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23. Enhanced Severe Acute Respiratory Syndrome Coronavirus 2 Antigen–Specific Systemic Immune Responses in Multisystem Inflammatory Syndrome in Children and Reversal After Recovery

Author

Kumar, Nathella Pavan, primary, Venkataraman, Aishwarya, additional, Nancy, Arul, additional, Moideen, Kadar, additional, Varadarjan, Poovazhagi, additional, Selladurai, Elilarasi, additional, Sangaralingam, Thankgavelu, additional, Selvam, Ramya, additional, Thimmaiah, Akshith, additional, Natarajan, Suresh, additional, Ramasamy, Ganesh, additional, Hissar, Syed, additional, Radayam Ranganathan, Umadevi, additional, and Babu, Subash, additional

Published
2022
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24. Differential Frequencies of Intermediate Monocyte Subsets Among Individuals Infected With Drug-Sensitive or Drug-Resistant Mycobacterium tuberculosis

Author

Sampath, Pavithra, primary, Natarajan, Alangudi Palaniappan, additional, Moideen, Kadar, additional, Kathamuthu, Gokul Raj, additional, Hissar, Syed, additional, Dhanapal, Madhavan, additional, Jayabal, Lavanya, additional, Ramesh, Paranchi Murugesan, additional, Tripathy, Srikanth Prasad, additional, Ranganathan, Uma Devi, additional, Babu, Subash, additional, and Bethunaickan, Ramalingam, additional

Published
2022
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25. Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Author

Chabala, Chishala, Turkova, Anna, Thomason, Margaret J., Wobudeya, Eric, Hissar, Syed, Mave, Vidya, van der Zalm, Marieke, Palmer, Megan, Kapasa, Monica, Bhavani, Perumal K., Balaji, Sarath, Raichur, Priyanka A., Demers, Anne-Marie, Hoddinott, Graeme, Owen-Powell, Ellen, Kinikar, Aarti, Musoke, Philippa, Mulenga, Veronica, Aarnoutse, Rob, McIlleron, Helen, Hesseling, Anneke, Crook, Angela M., Cotton, Mark, Gibb, Diana M., and on behalf of the SHINE trial team

Published
2018
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26. Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children

Author

Turkova, Anna, Wills, Genevieve H, Wobudeya, Eric, Chabala, Chishala, Palmer, Megan, Kinikar, Aarti, Hissar, Syed, Choo, Louise, Musoke, Philippa, Mulenga, Veronica, Mave, Vidya, Joseph, Bency, LeBeau, Kristen, Thomason, Margaret J, Mboizi, Robert B, Kapasa, Monica, van der Zalm, Marieke M, Raichur, Priyanka, Bhavani, Perumal K, McIlleron, Helen, Demers, Anne-Marie, Aarnoutse, Rob, Love-Koh, James, Seddon, James A, Welch, Steven B, Graham, Stephen M, Hesseling, Anneke C, Gibb, Diana M, Crook, Angela M, and SHINE Trial Team

Abstract

BACKGROUND: Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen. METHODS: We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence], loss to follow-up during treatment, or death) by 72 weeks, with the exclusion of participants who did not complete 4 months of treatment (modified intention-to-treat population). A noninferiority margin of 6 percentage points was used. The primary safety outcome was an adverse event of grade 3 or higher during treatment and up to 30 days after treatment. RESULTS: From July 2016 through July 2018, a total of 1204 children underwent randomization (602 in each group). The median age of the participants was 3.5 years (range, 2 months to 15 years), 52% were male, 11% had human immunodeficiency virus infection, and 14% had bacteriologically confirmed tuberculosis. Retention by 72 weeks was 95%, and adherence to the assigned treatment was 94%. A total of 16 participants (3%) in the 4-month group had a primary-outcome event, as compared with 18 (3%) in the 6-month group (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5). The noninferiority of 4 months of treatment was consistent across the intention-to-treat, per-protocol, and key secondary analyses, including when the analysis was restricted to the 958 participants (80%) independently adjudicated to have tuberculosis at baseline. A total of 95 participants (8%) had an adverse event of grade 3 or higher, including 15 adverse drug reactions (11 hepatic events, all but 2 of which occurred within the first 8 weeks, when the treatments were the same in the two groups). CONCLUSIONS: Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis. (Funded by the U.K. Medical Research Council and others; SHINE ISRCTN number, ISRCTN63579542.).

Published
2022

31. Pharmacokinetics of First-Line Drugs in Children With Tuberculosis, Using World Health Organization–Recommended Weight Band Doses and Formulations

Author

Chabala, Chishala, primary, Turkova, Anna, additional, Hesseling, Anneke C, additional, Zimba, Kevin M, additional, van der Zalm, Marieke, additional, Kapasa, Monica, additional, Palmer, Megan, additional, Chirehwa, Maxwell, additional, Wiesner, Lubbe, additional, Wobudeya, Eric, additional, Kinikar, Aarti, additional, Mave, Vidya, additional, Hissar, Syed, additional, Choo, Louise, additional, LeBeau, Kristen, additional, Mulenga, Veronica, additional, Aarnoutse, Robb, additional, Gibb, Diana, additional, and McIlleron, Helen, additional

Published
2021
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32. Additional file 1 of Plasma chemokines as immune biomarkers for diagnosis of pediatric tuberculosis

Author

Kumar, Nathella Pavan, Hissar, Syed, Thiruvengadam, Kannan, Banurekha, Velayuthum V., Balaji, Sarath, Elilarasi, S., Gomathi, N. S., Ganesh, J., Aravind, M. A., Baskaran, Dhanaraj, Tripathy, Srikanth, Swaminathan, Soumya, and Babu, Subash

Abstract

Additional file 1: Figure S1. The plasma levels of CCL1, CCL2, CCL3, CCL4, CCL11, CXCL1, CXCL2, CXCL9, CXCL10 and CXCL11 were measured in confirmed TB individuals at 6 months of anti-TB treatment (post-T) (n=24) and unlikely TB (n=76) individuals at baseline. The data are represented as scatter plots with each circle representing a single individual. P values were calculated using the Mann-Whitney test.

Published
2021
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33. Effects of co-administration of Unani pharmacopoeia formulations Qurs Tabasheer Sartani and Arq Hara Bhara with CAT-I antitubercular drugs in rats

Author

Ahmed, Noor Zaheer, primary, Agibothu Kupparam, Hemanth Kumar, additional, Akbar, Seema, additional, Hissar, Syed, additional, Anwar, Noman, additional, Thiruvengadam, Kannan, additional, Anjum, Nighat, additional, Khan, Asim Ali, additional, Dar, Showkat, additional, and Natarajan, Saravanan, additional

Published
2021
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34. Discovery and Validation of a Three-Cytokine Plasma Signature as a Biomarker for Diagnosis of Pediatric Tuberculosis

Author

Kumar, Nathella Pavan, primary, Hissar, Syed, additional, Thiruvengadam, Kannan, additional, Banurekha, Velayuthum V., additional, Suresh, N., additional, Shankar, Janani, additional, S, Elilarasi, additional, N S, Gomathi, additional, S, Kalpana, additional, J, Ganesh, additional, M A, Aravind, additional, Baskaran, Dhanaraj, additional, Tripathy, Srikanth, additional, Swaminathan, Soumya, additional, and Babu, Subash, additional

Published
2021
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43. Pharmacokinetics of First-Line Drugs in Children With Tuberculosis, Using World Health Organization–Recommended Weight Band Doses and Formulations.

Author

Chabala, Chishala, Turkova, Anna, Hesseling, Anneke C, Zimba, Kevin M, van der Zalm, Marieke, Kapasa, Monica, Palmer, Megan, Chirehwa, Maxwell, Wiesner, Lubbe, Wobudeya, Eric, Kinikar, Aarti, Mave, Vidya, Hissar, Syed, Choo, Louise, LeBeau, Kristen, Mulenga, Veronica, Aarnoutse, Robb, Gibb, Diana, and McIlleron, Helen

Subjects
DRUG therapy for tuberculosis, ETHAMBUTOL, PYRAZINAMIDE, ISONIAZID, RANDOMIZED controlled trials, ANTITUBERCULAR agents, DESCRIPTIVE statistics, PHARMACEUTICAL chemistry, RIFAMPIN, STATISTICAL sampling, CHILDREN
Abstract

Background Dispersible pediatric fixed-dose combination (FDC) tablets delivering higher doses of first-line antituberculosis drugs in World Health Organization–recommended weight bands were introduced in 2015. We report the first pharmacokinetic data for these FDC tablets in Zambian and South African children in the treatment-shortening SHINE trial. Methods Children weighing 4.0–7.9, 8.0–11.9, 12.0–15.9, or 16.0–24.9 kg received 1, 2, 3, or 4 tablets daily, respectively (rifampicin/isoniazid/pyrazinamide [75/50/150 mg], with or without 100 mg ethambutol, or rifampicin/isoniazid [75/50 mg]). Children 25.0–36.9 kg received doses recommended for adults <37 kg (300, 150, 800, and 550 mg/d, respectively, for rifampicin, isoniazid, pyrazinamide, and ethambutol). Pharmacokinetics were evaluated after at least 2 weeks of treatment. Results In the 77 children evaluated, the median age (interquartile range) was 3.7 (1.4–6.6) years; 40 (52%) were male and 20 (26%) were human immunodeficiency virus positive. The median area under the concentration-time curve from 0 to 24 hours for rifampicin, isoniazid, pyrazinamide, and ethambutol was 32.5 (interquartile range, 20.1–45.1), 16.7 (9.2–25.9), 317 (263–399), and 9.5 (7.5–11.5) mg⋅h/L, respectively, and lower in children than in adults for rifampicin in the 4.0–7.9-, 8–11.9-, and ≥25-kg weight bands, isoniazid in the 4.0–7.9-kg and ≥25-kg weight bands, and ethambutol in all 5 weight bands. Pyrazinamide exposures were similar to those in adults. Conclusions Recommended weight band–based FDC doses result in lower drug exposures in children in lower weight bands and in those ≥25 kg (receiving adult doses). Further adjustments to current doses are needed to match current target exposures in adults. The use of ethambutol at the current World Health Organization–recommended doses requires further evaluation. [ABSTRACT FROM AUTHOR]

Published
2022
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45. Additional file 2 of The recent trend in mycobacterial strain diversity among extra pulmonary lymph node tuberculosis and their association with drug resistance and the host immunological response in South India

Author

Sivakumar, Shanmugam, Yuvaraj Chandramohan, Gokul Raj Kathamuthu, Gomathi Sekar, Devika Kandhasamy, Venkatesan Padmanaban, Hissar, Syed, Srikanth P. Tripathy, Bethunaickan, Ramalingam, Dhanaraj, Baskaran, Subash Babu, and Ranganathan, Uma Devi

Abstract

Supplementary Fig. 1. Diminished plasma levels type 2 and type 17 cytokines associated with individuals infected with drug sensitive strain. The systemic levels of IL-4, IL-13, IL-17A and IL-22 were measured by ELISA between the drug sensitive (DS, n = 10) and orphan mono resistant (OMR, n = 3) strain infected individuals. The data were shown as bar graph and P values were calculated using the Mann-Whitney U test.

Published
2020
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46. Additional file 1 of The recent trend in mycobacterial strain diversity among extra pulmonary lymph node tuberculosis and their association with drug resistance and the host immunological response in South India

Author

Sivakumar, Shanmugam, Yuvaraj Chandramohan, Gokul Raj Kathamuthu, Gomathi Sekar, Devika Kandhasamy, Venkatesan Padmanaban, Hissar, Syed, Srikanth P. Tripathy, Bethunaickan, Ramalingam, Dhanaraj, Baskaran, Subash Babu, and Ranganathan, Uma Devi

Abstract

Supplementary Table 1. Demographic and clinical details of the study population

Published
2020
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48. Association of Plasma Matrix Metalloproteinase and Tissue Inhibitors of Matrix Metalloproteinase Levels With Adverse Treatment Outcomes Among Patients With Pulmonary Tuberculosis

Author

Kumar, Nathella P., primary, Moideen, Kadar, additional, Nancy, Arul, additional, Viswanathan, Vijay, additional, Thiruvengadam, Kannan, additional, Sivakumar, Shanmugam, additional, Hissar, Syed, additional, Nair, Dina, additional, Banurekha, Vaithilingam V., additional, Kornfeld, Hardy, additional, and Babu, Subash, additional

Published
2020
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